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The HemiCAP™ Patello-Femoral Resurfacing Prosthesis is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patellofemoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The FFL0-XXXX Patello-Femoral. Femoral Component, Large is a line extension to the Sponsor's previously cleared and commercially marketed HemiCAP™ Patello-Femoral Resurfacing Prosthesis.

This configuration is designed to allow for increased surface area of the femoral trochlear groove to provide greater coverage laterally as well as for increased flexion and extension anqles.

The proposed component is designed to mate with FFS1-XXXX Patello-Femoral Fixation Stud via taper interlock as well as the Sponsor's previously cleared and commercially marketed all-polyethylene patella component.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the HemiCAP™ Patello-Femoral Resurfacing Prosthesis, which focuses on demonstrating substantial equivalence to a predicate device. It defines the device, its intended use, and indicates the FDA's clearance, but does not include details on performance studies against specific acceptance criteria.

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